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510(k) Data Aggregation

    K Number
    K040969
    Device Name
    POISE DATAENGINE
    Manufacturer
    POISE TECHNOLOGY CORPORATION
    Date Cleared
    2004-06-08

    (55 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    POISE TECHNOLOGY CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
    Device Description
    DataEngine is a comprehensive solution to integrate medical device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
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